Events

Safety Alert for Samaritan PDU 400

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by HeartSine Technologies Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: heartsine samaritan pdu 400 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pdu 400, manufactured by heartsine technologies ltd. the affected serial numbers are from 08p00001003 to 11p00007347. the software of samaritan pdu 400 device may fail to accurately determine the remaining capacity of the device battery. rather than emitting an alarm warning users that the device has insufficient battery to deliver therapy, the device may simply shut down. the affected device may be unable to operate during a sudden cardiac arrest. the manufacturer will arrange replacement of the affected pdu 400 devices for users. according to the regional distributor in singapore, the affected products were not distributed in hong kong. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

Samaritan PDU 400
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartSine Samaritan PDU 400
  • Manufacturer
    HeartSine Technologies Ltd

Manufacturer

HeartSine Technologies Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH